Month: May 2020

Pharmacists Authorized to Order and Administer COVID-19 Tests, Regardless of State Law

21 May, 2020 no responses

The Office of the General Counsel at the Department of Health and Human Services (HHS) has issued an advisory opinion stating that HHS’s guidance authorizing pharmacists to order and administer COVID-19 tests pursuant to the Public Readiness and Emergency Preparedness Act supersedes any state law that would prohibit pharmacists from ordering tests.

Specifically, the advisory opinion refers to utilizing a “qualified person” for COVID-19 response. HHS Secretary Alex Azar declared pharmacists to be a “qualified person” for the purposes of ordering and administering COVID-19 tests on April 8.

ASHP has actively advocated for the ability for pharmacists to order and administer tests in response to COVID-19. We will continue to work with our state affiliates on implementation of emergency orders and seek information on reimbursement for services from the Centers for Medicare & Medicaid Services. We are following up with HHS to determine whether this nationwide authority to conduct testing applies to influenza in addition to COVID-19.

Emergency Use Authorization (EUA) for Propoven

8 May, 2020 no responses

On May 8, 2020, FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, to maintain sedation via continuous infusion in patients older than 16 years of age who require mechanical ventilation in an intensive care unit (ICU) setting during the COVID-19 pandemic.

Because Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion has a concentration twice that of the FDA-approved propofol product, there is a risk of unintentional overdose. There are also important differences in the formulation and labeling between the two products. Healthcare providers should review the EUA and the differences between the two products prior to administering Propoven. Documents related to the EUA can be found here, including the most recent letter of authorization, a fact sheet on the EUA for healthcare providers, and a wall chart outlining the key differences between the two products.

Emergency Use Authorization (EUA) for Remdesivir

1 May, 2020 no responses

Today, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.

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